Stelara (Ustekinumab) Shows Sustained Symptomatic and Corticosteroid-Free Remission in Ulcerative Colitis Patients Through Nearly Three Years in Phase 3 Long-Term Extension Study

Ulcerative Colitis (UC, Image source: healthjade.com)

July 10, 2021 /Bio ValleyBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced new three-year data from the long-term extension (LTE) of the Phase 3 UNIFI study evaluating the anti-inflammatory drug Stelara (Chinese brand name: Xidano; generic name: ustekinumab; ustekinumab injection) in adult patients with moderately to severely active ulcerative colitis (UC). The results showed that among patients who initially responded to Stelara treatment,Most patients (55.2%) maintained symptomatic remission at approximately 3 years (Week 152).Additionally, among patients who achieved symptom relief at Week 152,The majority (96.4%) were not receiving corticosteroid therapy (corticosteroid-free), i.e., corticosteroid-free remission.

Despite substantial therapeutic advances in recent years, many patients with UC still struggle to achieve sustained remission of their disease symptoms, particularly without corticosteroids, the long-term use of which can lead to debilitating side effects. The LTE results from the UNIFI study underscore the importance of long-term evaluation of therapeutic agents,Data demonstrate that Stelara is an effective and durable treatment option for patients with moderate to severe active ulcerative colitis (UC).

In the intent-to-treat (ITT) population, among the 348 patients who achieved a clinical response at the start of the maintenance phase (maintenance baseline) and were randomized to Stelara 90 mg every 8 weeks (q8w) or every 12 weeks (q12w): (1) 55.2% of patients (192/348) maintained clinical remission at Week 152; (2) 96.4% (185/192) of patients maintained clinical remission at Week 152 without corticosteroid treatment.

Among the 248 patients randomized to Stelara 90 mg q8w or q12w at the start of the maintenance phase and treated during the long-term extension (LTE): (1) 67.6% of patients maintained symptomatic remission at Week 152; (2) among patients in clinical remission at Week 44, 76.4% maintained symptomatic remission at Week 152.

An analysis of the impact of corticosteroids during the UNIFI LTE showed that among Stelara patients receiving corticosteroid therapy at the start of the maintenance phase (n=139), 91.4% were no longer receiving corticosteroid therapy at Week 152 (patients were randomized to Stelara at the start of the LTE for the UNIFI study).

Safety was assessed for all patients who received treatment during the LTE through Week 156 (n=588). From Week 0 of the maintenance phase through Week 156, the total follow-up time for the pooled Stelara group and the placebo group was 1281.6 and 425 patient-years (PY), respectively. The incidence rates per 100 PY of follow-up were as follows: adverse events (AE), 235.81 in the Stelara group vs 204.48 in the placebo group; serious adverse events (SAE), 7.73 vs 7.53; and serious infections, 2.34 vs 2.35. No new safety signals were observed.

Jan Wehkamp, M.D., Vice President and Head of Gastroenterology at Janssen Research & Development, said: “Janssen has remained focused on unmet patient needs and is committed to advancing the standard of care for ulcerative colitis (UC). We are proud to share these long-term data with the gastroenterology community, particularly for patients who continue to strive for disease control and remission.”

Stelara is the world's first biologic agent that simultaneously and selectively targets IL-12 and IL-23. IL-12 and IL-23 are two naturally occurring cytokines believed to play a pivotal role in immune-mediated inflammatory diseases, including UC, plaque psoriasis, psoriatic arthritis, and Crohn's disease. Stelara inhibits these two pro-inflammatory cytokines by binding to the p40 subunit shared by IL-12 and IL-23, thereby preventing their binding to the cell surface receptor IL-12Rβ1.

Stelara was launched in September 2009. The currently approved indications include the treatment of: (1) moderate-to-severe plaque psoriasis (PsO) in adolescents (≥6 years) and adults; (2) active psoriatic arthritis (PsA) in adults; (3) moderate-to-severe Crohn's disease (CD) in adults; and (4) moderate-to-severe active ulcerative colitis (UC) in adults.

In China,Stelara (Xidano®) was first approved in November 2017 and has been approved for two indications to date.: (1) indicated for adult patients with moderate to severe plaque psoriasis (PsO) who have not responded to, have contraindications to, or are intolerant to other systemic therapies such as cyclosporine, methotrexate (MTX), or PUVA (psoralen and ultraviolet A); (2) indicated for patients who have not responded to, have contraindications to, or are intolerant to conventional therapy orTumorAdult patients with moderate to severe active Crohn's disease (CD) who have had an inadequate response, loss of response, or intolerance to tumor necrosis factor-alpha (TNF-α) antagonists.

`Stelara is Johnson & Johnson's foray into`Autoimmunitya core product in the [...] disease therapeutic area. This drug achieved sales of $7.707 billion in 2020, representing a year-on-year growth of 21.1% compared to the previous year. (Bioon.com)

Original Source:STELARA® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Rates in Adults with Moderately to Severely Active Ulcerative Colitis at Nearly Three Years in Long-Term Extension of Phase 3 Trial